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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problems Fluid Leak (1250); Excess Flow or Over-Infusion (1311); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving morphine (unknown concentration and dose) and prialt (unknown concentration and dose) via an implantable pump for an unknown indication for use. It was reported a problem appeared during the filling of the pump. The event date was unknown. It was stated there were very big differences between the volumes announced by the n'vision and the volume found in the pump. It was stated the hcp had the "impression that the pump flight. Because during fillings, there were differences of very important volumes. Indeed, at the level of the septum, it would seem that the pump flight. The nurses use needles of 20 gauges which certainly conned the septum and caused the flights. " it was stated no troubleshooting was performed. By precaution, the hcp preferred to change the pump and catheter. The replacement occurred on (b)(6) 2018. When prompted for contributing factors to the event, the response was, "for two once, the stomach of the patient pearled at the time of the filling. " the issue was resolved. The patient status was alive - no injury. The pump and catheter would be returned. No further complications were reported or anticipated. The patient was receiving morphine (1. 5 mg/ml at 0. 6994 mg/day) and prialt (4. 0 mg/ml at 1. 8651 mg/day). The volume the pump announced was 16. 5 ml and the representative found 0 ml. When asked what "pump flight" means, the representative responded, "none, it¿s a mistake. " when asked what "conned the septum" means, the representative responded, "the septum is the center of the pump. " when asked what "stomach of the patient pearled" means, the representative responded, "the drug is flowing through the patient's skin. " the representative stated the model of the patient's catheter was 8780. The patient did not experience any symptoms.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Corrected information. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7611446
MDR Text Key111398635
Report Number3004209178-2018-13699
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2017
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/18/2018 Patient Sequence Number: 1
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